Company ยท US
Clark Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1998. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 5 |
| LSE | Epstein-Barr Virus, Other | 3 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 |
| MJH | Legionella, Spp., Elisa | 1 |
| PCL | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 1998 | K980912 | VCA IGG ELISA TEST SYSTEM Clark Laboratories, Inc. | LSE |
| Jul 22, 1998 | K980596 | VCA IGM ELISA TEST SYSTEM Clark Laboratories, Inc. | LSE |
| May 1, 1998 | K980598 | EBNA-1 IGM ELISA TEST SYSTEM Clark Laboratories, Inc. | LLM |
| Mar 26, 1998 | K973123 | EA-D IGG ELISA TEST SYSTEM Clark Laboratories, Inc. | LSE |
| Sep 8, 1993 | K931543 | ENCORE ENA COMBINED EIA Clark Laboratories, Inc. | LLL |
| Jan 26, 1993 | K925826 | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA Clark Laboratories, Inc. | JZO |
| Dec 23, 1992 | K923537 | ENCORE DS-DNA Clark Laboratories, Inc. | LRM |
| Dec 1, 1992 | K921870 | ENCORE SM/RNP Clark Laboratories, Inc. | LLL |
| Dec 1, 1992 | K921572 | ENCORE SM Clark Laboratories, Inc. | LLL |
| Oct 16, 1992 | K922340 | ENCORE SS-B Clark Laboratories, Inc. | LLL |
| Oct 13, 1992 | K922157 | ENCORE SS-A Clark Laboratories, Inc. | LLL |
| Sep 25, 1992 | K924056 | ENCORE RHEUMATOID FACTOR EIA Clark Laboratories, Inc. | DHR |
| Aug 27, 1992 | K921573 | RUBELLA IGM Clark Laboratories, Inc. | LFX |
| Mar 18, 1992 | K920150 | ENCORE SCL-70 Clark Laboratories, Inc. | LKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2021 | Clark Laboratories, Inc. Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen Terminated |
MJH | K991074 |
| Mar 17, 2021 | Clark Laboratories, Inc. Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) Terminated |
PCL | K140455 |